Companion diagnostics: legislation in progress - .PDF file.
By Dr Manja Epping and Steffen Wirsing
In September 2012, the European Commission adopted a proposal for a regulation on in-vitro diagnostic medical devices that included certain specific provisions regarding the classification and conformity assessment of devices used in the context of personalised medicine, so-called companion diagnostics.
Meanwhile, the responsible committee on the environment, public health and food safety (ENVI) published its report. On 22 October, the European Parliament voted on the Commission proposal and the amendments suggested by the committee and agreed on a new proposal that contains some significant changes affecting companion diagnostics.
A companion diagnostic is now defined more precisely as a ‘device specifically intended for and essential to the selection of patients with a previously diagnosed condition or predisposition as suitable or unsuitable for a specific therapy with a medicinal product or a range of medicinal products’…
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